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Why Biohaven Stock Zoomed More Than 6% Higher Today
Biohaven .Biohaven .(US:BHVN) The Motley Foolยท2025-08-22 22:18

Core Viewpoint - Biohaven's stock experienced a significant increase of over 6% following positive regulatory news from the FDA regarding its New Drug Application for troriluzole, outperforming the S&P 500 index's 1.5% gain on the same day [1]. Regulatory Progress - Biohaven disclosed in a filing with the SEC that the FDA informed the company that an advisory committee meeting for the New Drug Application (NDA) for troriluzole is no longer necessary [2]. - Troriluzole is aimed at treating spinocerebellar ataxia, a group of inherited neurological disorders affecting movement, and the drug's development faced initial setbacks, including the FDA's refusal to accept the filing [4]. Implications of Advisory Meeting Cancellation - The cancellation of the advisory meeting suggests that the FDA may have already made a decision regarding the NDA, although it does not guarantee a favorable outcome for Biohaven [5]. - Research indicates that approximately two-thirds of applications with canceled advisory meetings have received approval from the FDA since 2019, which explains the market's positive reaction to the news [6].